Effect of Combined Resisted Training and Protein-based Diet on Frailty in Sarcopenic Elderly Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: supervised resistance exercise training and a, high -protein diet.
- Who it may be relevant to
- Registry conditions: Obese, Sarcopenic Obesity. Basic parameters: 60 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Sixty obese elderly women will be recruited from Fawkia hospital outpatient clinic diagnosed by sarcopenia and randomly allocated into two groups for a 12-week intervention. Patients will be divided into 2 groups (A and B): * Group A (combined intervention group: n=30): will perform supervised resistance exercise training three times per week and follow a high-protein diet (1.3 g protein/kg/day) * Group B (control group: n=30): will receive a high-protein diet and general health advices and be asked to maintain their usual lifestyle. They will be offered the intervention post-study.
Detailed description
Group A (combined intervention):
Resistance Exercise:
The exercise program involved resistance training 3 days a week for 1-h sessions. The training started with a 10-min warming up followed by two sets of 50 s of the following exercises: leg press, knee extensions, leg curls, chest press, seated row, plantar flexion, and sit-to-stand exercises. During the 12-week period the number of sets was gradually increased from 2 - 3 set for all exercises, the time to perform the exercises increased from 50 - 75 s, and resistance was increased by using dumbbells, elastic bands, medicine balls and a step bench. The training ended with 5-min cooling down. Attendance to the training sessions was recorded.
Dietary intervention:
* Protein intake: 1.3 grams of protein per kilogram of body weight per day. * Distribution: protein intake will be evenly distributed across meals (≥ 30g per meal). * Monitoring: participants will keep 3-day dietary records every two weeks. Group B (control group): will receive high protein plan and a single session of general advices on the importance of physical activity based on national guidelines. They will be contacted every two weeks for general check-ins to maintain engagement but will not receive structured exercise or dietary planning.
Interventions
- Other supervised resistance exercise training and a
supervised resistance exercise training three times per week - Other high -protein diet
a high-protein diet (1.3 g protein/kg/day)
Primary outcome measures
- balance assessment [Time frame: 12 weeks]
Secondary outcome measures (6)
- Health-Related Quality of Life [Time frame: 12 weeks]
- hallmarks of sarcopenia [Time frame: 12 weeks]
- Muscle quality index [Time frame: 12 weeks]
- Handgrip strength assessment [Time frame: 12 weeks]
- Waist-to-hip ratio assessment [Time frame: 12 weeks]
- body mass index [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 1\) Female gender 2) Age 60-70 years 3) BMI ≥ 30 kg/m2 4) Sarcopenic patients diagnosed by their physicians according to EWGSOP2 criteria (low muscle strength confirmed by handgrip strength or chair stand test, plus low muscle quantity confirmed by BIA or DXA), and SARC-F score >3.
5\) Ambulatory and able to participate in exercise. 6) Stable medical condition. 7) The patients didn't follow any type of diet before the treatment at least 4 weeks ago.
8\) Patients didn't follow any exercise program before treatment at least 4 weeks ago.
Exclusion criteria
- 1\) Sever cardiovascular, pulmonary, renal, or hepatic disease. 2) Uncontrolled diabetes or hypertension. 3) Neurological or musculoskeletal disorders prohibiting exercise 4) Cancer or other terminal illness. 5) Current use of anti-inflammatory drugs or steroids. 6) Metal implants prohibiting BIA assessment. 7) Cognitive impairment impairing ability to consent or follow instructions. 8) Using drugs that would affect metabolism or balance. 9) Using assistive devices for walking.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Fawkia hospital outpatient clinic — El-Sheikh Zayed City
Identifiers
NCT: NCT07627919 · P.T.REC/012/006131